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A therapy using bone-marrow stem cells to promote heart repair did not significantly improve the primary outcome over sham procedures in patients with congestive heart failure. The CHART-1 trial, reported in an ESC HOT LINE session on Sunday, did however identify a subgroup of patients with severe heart enlargement benefitting from therapy.
The CHART-1 trial, representing the largest- ever study testing cardiopoietic stem cells in heart failure, randomised 120 patients to receive the cells versus 151 given a sham procedure. Results at 39 weeks showed there was no significant difference between groups for the primary efficacy endpoint – a composite of all-cause mortality, worsening heart failure events, Minnesota Living with Heart Failure Questionnaire total score, 6-minute walk distance, left ventricular end-systolic volume and ejection fraction (p=0.27). An exploratory subgroup analysis of patients with severe heart enlargement at baseline (defined as left ventricular end-diastolic volumes between 200 and 370 mL), accounting for 60% of all patients in the study, showed positive effects on the primary efficacy endpoint (p=0.015). Additionally, there was found to be greater benefit among patients who underwent fewer injections.
‘The CHART-1 trial identified a clinically relevant patient population with elevated baseline end-diastolic volume that benefited from cardiopoietic cell treatment,’ said study presenter Jozef Bartunek, from OLV Hospital, Aalst, Belgium. Optimized treatment intensity together with disease severity targeted patient selection, he added, should be considered in future trials.
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